Leaflet: information for the user

Tadalafilo Tarbis Farma 5 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isTadalafilo Tarbis Farmaand what is it used for

2. What you need to know before starting to takeTadalafilo Tarbis Farma

3. How to takeTadalafilo Tarbis Farma

4. Possible side effects

5. Storage ofTadalafilo Tarbis Farma

6. Contents of the pack and additional information

Tadalafilo Tarbis Farma contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo 5 mg is used to treat adult men with:

• erectile dysfunction. This occurs when a man is unable to obtain or maintain a firm erection, suitable for a satisfactory sexual activity. Tadalafilo has shown a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not help if you do not have erectile dysfunction. It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, and the need to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Tarbis Farma if:

• You are allergic to tadalafilo or any of the other components of this medication (listed in section 6).
• You are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafilo has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• You have a serious heart disease or have had a heart attack recently, within the last 90 days.
• You have had a recent stroke, within the last 6 months.
• You have low or uncontrolled high blood pressure.
• You have ever presented vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarct”.
• You are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as tadalafilo, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take this medication.

Be aware that sexual relations carry a possible risk for patients with heart problems, due to the additional effort they impose on the same. If you have a heart problem, consult with your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with tadalafilo for benign prostatic hyperplasia. Tadalafilo does not treat prostate cancer.

Before taking the tablets, inform your doctor if you have:

• Anemia falciforme (a red blood cell abnormality).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any penile deformity.
• A serious liver problem.
• A serious kidney problem.

It is not known if tadalafilo is effective in patients who have undergone:

• Surgery in the pelvic area.
• A surgical intervention in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision or your vision is distorted, blurred while taking tadalafilo, stop taking this medication and immediately contact your doctor.

A sudden decrease or loss of hearing has been observed in some patients taking tadalafilo. Although, it is not known if the event is directly related to tadalafilo, if you experience a sudden decrease or loss of hearing, stop taking this medication and immediately contact your doctor.

Tadalafilo is not intended for use in women.

Children and adolescents

Tadalafilo should not be used in children or adolescents under 18 years old.

Other medications and Tadalafilo Tarbis Farma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take tadalafilo if you are already using nitrates.

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo. Inform your doctor or pharmacist if you are using:

• An alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• Other medications to treat high blood pressure.
• Riociguat.
• An inhibitor of 5-alpha reductase (used to treat benign prostatic hyperplasia).
• Medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafilo Tarbis Farma with beverages and alcohol

The information about the effect of alcohol is found in section 3. Orange juice may affect the proper functioning of tadalafilo and should be taken with caution. Consult your doctor for more information.

Fertility

In treated dogs, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Some men who took tadalafilo during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machinery.

Tadalafilo Tarbis Farma contains lactose

If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Tadalafilo Tarbis Farma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablets of this medication are for oral administration only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

The consumption of alcohol may temporarily decrease your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil.

This will be done by taking one 2.5 mg tablet. As Tadalafilo Tarbis Farma is not available in 2.5 mg film-coated tablets, check the availability of other suitable formulations.

Do not take tadalafil more than once a day.

Tadalafil administered daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Daily tadalafil may be useful for men who anticipate engaging in sexual activity two or more times a week.

It is essential to inform you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once a day, approximately at the same time. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take tadalafil more than once a day.

If you take more Tadalafilo Tarbis Farma than you should

Consult your doctor. You may experience adverse effects described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tadalafilo Tarbis Farma

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take tadalafil more than once a day.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

If you experience any of the following side effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rashes (infrequent).
• chest pain - do not use nitrates but seek medical help immediately (infrequent).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted, blurred, or decreased central vision, or sudden vision loss (unknown frequency).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Infrequent(may affect up to 1 in 100 people):

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding, tinnitus, swelling of the hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1,000 people):

• syncope, seizures, and transient loss of memory, eyelid swelling, red eyes, sudden hearing loss, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen, and increased sweating.

Infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had some heart problem before taking this medicine.

Rarely, cases of partial or permanent loss of vision, temporary or permanent, in one or both eyes have been reported.

Some rare additional side effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted, blurred, or decreased central vision, or sudden vision loss (unknown frequency).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Tadalafilo Tarbis Farma

The active ingredient is tadalafil.

Each film-coated tablet contains 5 mg of tadalafil.

The other components are:

Core of the tablet:Lactose monohydrate, copovidone, anhydrous colloidal silica, hydroxyestearate of macrogolglycerol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate,

Coating:Hydroxypropyl methylcellulose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b).

Appearance of the product and content of the container

Film-coated tablets, biconvex, round, white in color, engraved with “T17” on one face and “H” on the other.

Blister containing 14, 28, 30, 56, 84, 98, and 100 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Tadalafil Amarox 5 mg Filmtabletten

Netherlands:Tadalafil Amarox 5 mg filmomhulde tabletten

Spain:Tadalafilo Tarbis Farma 5 mg comprimidos recubiertos con película EFG

Date of the last review of this leaflet: March 2024

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/